Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

CDRH: IDEs Submitted Under Early Feasibility Program Have More Than Doubled

The number of investigational device exemptions submitted under CDRH’s Early Feasibility Study Program has more than doubled, with 57 submitted in FY 2017 up from 26 when the agency issued EFS guidance in 2013.

Agency officials said 75 percent of IDEs submitted over the last two years have received timely FDA approval within the 30-day review cycle.

Approximately half of EFS IDEs are submitted by small medical device manufacturers. The program is intended to aid study sponsors, especially those with limited financial resources, during early clinical evaluations of new medical technologies.